Preparing for a Pandemic, State Health Departments Struggle With Rationing Decisions

by Sheri Fink, ProPublica

New York state health officials recently laid out this wrenching scenario for a small group of medical professionals from New York-Presbyterian Hospital:

A 32-year-old man with cystic fibrosis is rushed to the hospital with appendicitis in the midst of a worsening pandemic caused by the H1N1 flu virus, which has mutated into a more deadly form. The man is awaiting a lung transplant and brought with him the mechanical ventilator that helps him breathe.

New York’s governor has declared a state of emergency and hospitals are following the state’s pandemic ventilator allocation plan -- actual guidelines drafted in 2007 that are now being revisited. The plan aims to direct ventilators to those with the best chances of survival in a severe, 1918-like flu pandemic where tens of thousands develop life-threatening pneumonia.

Because the man’s end-stage lung disease caused by his cystic fibrosis is among a list of medical conditions associated with high mortality, the guidelines would bar the man from using a ventilator in a hospital, even though he is, unlike many with his illness, stable, in good condition, and not close to death. If the hospital admits him, the guidelines call for the machine that keeps him alive to be given to someone else.

Would doctors and nurses follow such rules? Should they?

In recent years, officials in a host of states and localities, as well as the federal Veterans Health Administration, have been quietly addressing one of medicine’s most troubling questions: Who should get a chance to survive when the number of severely ill people far exceeds the resources needed to treat them all?

The draft plans vary. In some states, patients with Do Not Resuscitate orders, the elderly, those requiring dialysis, or those with severe neurological impairment would be refused ventilators, or admission to hospitals. Utah divides epidemics into phases. Initially, hospitals would apply triage rules to residents of mental institutions, nursing homes, prisons and facilities for the “handicapped.” If an epidemic worsened, the rules would apply to the general population.

Federal officials say the possibility that America’s already crowded intensive care units would be overwhelmed in the coming weeks by flu patients is small but they remain vigilant.

The triage plans have attracted little publicity. New York, for example, released its draft guidelines in 2007, offered a 45-day comment period, and has made no changes since. The Health Department made 90 pages of public comments public this week only after receiving a request under the state’s public records laws.

Mary Buckley-Davis, a respiratory therapist with 30 years experience, wrote to officials in 2007 that “there will be rioting in the streets” if hospitals begin disconnecting ventilators. “There won’t be enough public relations spin or appropriate media coverage in the world” to calm the family of a patient “terminally weaned” from a ventilator, she said.

State and federal officials defend formal rationing as the last in a series of steps that would be taken to stretch scarce resources and provide the best outcome for the public. They say it is better to plan for such decisions than leave them to besieged health workers battling a crisis.

“You change your perspective from thinking about the individual patient to thinking about the community of patients,” said Rear Adm. Ann Knebel of the Department of Health and Human Services.

But some health professionals question whether the draft guidelines are fair, effective, ethical, and even remotely feasible.

Most existing triage plans were designed for handling mass casualties. They sort injured victims into priority categories based on the urgency of their medical needs and their potential for survival given available resources. Much of the controversy over the state plans focuses on two additional features.

These are “exclusion criteria,” which bar certain categories of patients from standard hospital treatments in a severe health disaster, and “minimum qualifications for survival,” which limit the resources used for each patient. Once that limit is reached, patients who are not improving would be removed from essential treatment in favor of those with better chances.

A version of these concepts was outlined in a post-9/11 medical journal article that suggested ways to handle victims of a large-scale bioterrorist event. The author, Dr. Frederick Burkle Jr., said he based his ideas in part on his experiences as a triage officer in Vietnam and the gulf war and on a cold war-era British plan for coping with a nuclear strike. Dr. Burkle said that during the gulf war he once instructed surgeons to halt an operation and work on another patient who was more likely to survive. Surgeons later returned to the first patient.

Dr. Burkle’s ideas were key aspects of guidelines Ontario authorities drew up after SARS to plan for avian flu and other pandemics. This approach and one by a team of Minnesota doctors were modified by groups developing similar guidelines in the United States.

There were important distinctions. Dr. Burkle’s original paper did not anticipate withdrawing care from patients and stressed the need to reassess the level of supplies “sometimes on a daily or hourly basis” in a fluid effort to provide the best possible care.

Some states’ triage guidelines are rigid, with a single set of criteria intended to apply throughout the severe phase of a pandemic. That disturbs Dr. Burkle. “I have said to my wife, I think I developed a monster here,” he said.

Recent research highlights the problem of a one-size-fits-all approach to triage. Many state pandemic plans call for hospitals to remove patients from ventilators if they are not improving after two to five days. Studies show that people severely ill with H1N1 flu generally need a week to two weeks on ventilators to recover.

There is also controversy over what values and ethical principles should guide triage decisions, how to engage the public, and whether withdrawing life support in the hospital and withholding it at the hospital door are distinct.

Normally, removing viable patients from life support against their or their families’ will would be considered murder. The New York-Presbyterian Hospital employees who participated in the recent exercise said they would not comply unless given legal protection.

They also never figured out what to do with that hypothetical patient who had his own ventilator, said Dr. Kenneth Prager, a pulmonologist and ethicist. “The issue of removing patients from ventilators,” he said, “was so overwhelming that it precluded discussion of further case scenarios.”

ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest.

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Early results From Clinical Trials Of 2009 H1N1 Influenza Vaccines In Healthy Adults

We are encouraged by reports that are now emerging from various clinical trials of 2009 H1N1 influenza vaccines, conducted by various vaccine manufacturers. We expect additional companies to announce their preliminary trial results shortly. The early data from these trials indicate that 2009 H1N1 influenza vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15-microgram dose. We congratulate the companies on these trials, which are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines. More than 2,800 people are participating in ongoing NIAID trials of these vaccines.

We are pleased to note that preliminary analyses of early data from the NIAID trials align with the recently announced findings and those to be announced imminently by other companies in that both vaccines studied induced what is likely to be a protective immune response in most adults following a single dose in the same amount (15 micrograms) used in seasonal flu vaccines. Specifically, in blood samples obtained 8 to 10 days after vaccination

Among healthy adults who received a single 15-microgram dose of the Sanofi Pasteur vaccine, a robust immune response was measured in 96 percent of adults aged 18 to 64 and in 56 percent of adults aged 65 and older.

Similarly, among healthy adults who received a single 15-microgram dose of the CSL Limited vaccine, a robust immune response was measured in 80 percent of adults aged 18 to 64 and in 60 percent of adults aged 65 and older.

Additional data from the NIAID trials are forthcoming. However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines.

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Learning From Both Ends of The Stethoscope

A systematic review of studies published over the past four decades has confirmed that good doctor-patient communication makes a difference not only in patient satisfaction but in patient outcomes including resolution of chronic headaches, changes in emotional states, lower blood sugar values in diabetics, improved blood pressure readings in hypertensives, and other important health indicators.

The review, published by researchers from the Indiana University School of Medicine and the Regenstrief Institute, Inc. and colleagues from the US Centers for Disease Control and Emory University, appears in the April 2007 issue of Medical Care, a journal of the American Public Health Association.

“In looking at these 36 studies we learned many things. For example, research on non-adherence to doctor’s instructions has focused on bad or poor behavior by patients rather than on the clarity of the physician’s instructions or whether the physician actually checked to see if his or her instructions were understood by the patient. The physician assumed that the patient understands and thus will comply. But is this a logical assumption? We don’t assume that when a pilot and an air traffic controller converse that they have understood each until there is an affirmation of understanding. That acknowledgement is lacking in most patient-physician encounters,” says Richard Frankel, IU School of Medicine professor of medicine and Regenstrief Institute research scientist, senior author of the study.

Frankel is a sociologist who studies ways to improve the doctor-patient relationship. He is currently investigating how behavioral changes by both doctors and patients impact medical care.

“From previous work, including a well regarded 1999 study from the University of Washington, we know that doctors ask patients whether they understand what was discussed during a medical appointment only about 1.5 percent of the time,” Frankel says. “It is extremely important that a patient be given the opportunity and probably even encouraged to ask questions. Doctors should be trained to routinely check for understanding to ensure that there is neither miscommunication nor mismatch between what the patient wants and what doctors assume the patient wants.”

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Rand Panel Makes Recommendations To Respond To Pandemic

A panel of experts convened by the RAND Corporation has recommended actions that communities around the United States should take to be better prepared to deal with bioterrorist attacks, pandemic flu outbreak and other large-scale public health emergencies.

The recommendations announced by RAND, a nonprofit research organization, consist of 16 actions listed under three broad categories. They call for communities to:

• Have a coordinated rapid-response capability. This should include well-defined roles and responsibilities for officials and the public; a clear command structure; strong public communications; the ability to provide emergency health care to large numbers of people; and the ability to monitor the spread of a public health emergency.
• Develop and maintain adequate numbers of operations-ready public health workers and volunteers.
• Engage in a continuous process of testing, improvement and maintenance of systems for tracking and reporting information on readiness to decision-makers and the public.
  

“The panel's work provides a clear, new definition of public health emergency preparedness and describes the critical ingredients that constitute a prepared community,” says Christopher Nelson, lead author of the report that was produced by RAND Health's Center for Domestic and International Health Security. “This will not only help communities and government agencies figure out where the gaps are, but also where future investments should be made.”

The panel defined public health emergency preparedness as: “The capability of the public health and health care systems, communities and individuals to prevent, protect against, quickly respond to and recover from health emergencies, particularly those whose scale, timing or unpredictability threatens to overwhelm routine capabilities. Preparedness involves a coordinated and continuous process of planning and implementation that relies on measuring performance and taking corrective action."

The proposed RAND definition emphasizes that responsibility for public health preparedness lies not only with governmental agencies but also with active, engaged and mobilized community residents, businesses, and non-governmental organizations.

The definition also states that preparedness should build upon day-to-day public health systems and be regularly tested.

“If you ask public health and government officials, ‘What is a public health emergency?' no two people will give you the same answer,” says Nicole Lurie, MD, co-director of the RAND Center for Domestic and International Health Security. “Without a clear definition of what a public health emergency is and how to prepare for one, communities and states cannot assess whether or not they are prepared.”

“It's not enough to just have a plan for public health emergencies,” Nelson says. “Communities need to have tested all the elements to make sure these plans will work in a time of crisis.”

"The conceptualization and definition of public health preparedness proposed in this editorial is concise, clear and to the point," says Paul Jarris, MD, executive director of the Association of State and Territorial Health Officials. "The authors provide a framework to guide the development of performance metrics and continuous improvement of our nation's public health readiness."

The report from the RAND Health panel, chaired by former Virginia governor and 2008 Republican presidential candidate James Gilmore III, appears online as an editorial in the Public Health Preparedness supplement to the April issue of the American Journal of Public Health. It is titled “Conceptualizing and Defining Public Health Emergency Preparedness.” The report was funded by the U.S. Department of Health and Human Services.

Since the terrorist attacks of Sept. 11, 2001, the U.S. government has invested more than $5 billion to increase the country's ability to prepare for and respond to public health emergencies.

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Foundation Announces $500 Million Commitment to Reverse Childhood Obesity in U.S.

The Robert Wood Johnson Foundation (RWJF) today announced it will commit at least $500 million over the next five years to tackle one of the most urgent public health threats facing the United States: childhood obesity. This is the largest commitment by any foundation to this issue, RWJF says. The foundation's goal is to reverse the epidemic of childhood obesity in the United States by 2015.

During the past four decades, obesity rates have soared among all age groups, more than quadrupling among children ages 6 to 11. Today, more than 33 percent of children and adolescents -- approximately 25 million kids -- are overweight or obese.

Preventing obesity during childhood is critical, because habits that last into adulthood frequently are formed during youth. Research shows that overweight adolescents have up to an 80 percent chance of becoming overweight or obese adults. Earlier onset of obesity leads to the earlier onset of related illnesses, such as type 2 diabetes, heart disease, stroke, and certain types of cancer.

In addition to the toll on U.S. health, obesity also poses a tremendous financial threat to the U.S. economy and health care system. It's estimated that the obesity epidemic costs the United States $117 billion per year in direct health care costs and lost productivity. Childhood obesity alone carries a huge price tag -- up to $14 billion per year in direct healthcare costs to treat kids.

"This is an all-American crisis," says Dr. Risa Lavizzo-Mourey, M.D., M.B.A., president and CEO of RWJF. "It affects all Americans, and it will require all of America working together to turn it around. Our commitment is a call to action for families, schools, government, industry, healthcare and philanthropy. To reverse the obesity epidemic and create a culture of health, we must provide families with better access to healthy choices."

The foundation says it will focus on improving access to affordable healthy foods and opportunities for safe physical activity in schools and communities. It will place special emphasis on reaching children at greatest risk for obesity and related health problems: African-American, Latino, Native American, Asian American and Pacific Islander children living in low-income communities.

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Changes To Better Respond To Flu Pandemic Urged

The American Public Health Association (APHA) recommends key changes to the U.S. strategy for preparing and responding to a flu pandemic to ensure the health and safety of all individuals, the association for public health professionals founded in 1872 says.

APHA released a blueprint for improving U.S. pandemic preparedness, amid persistent concerns about a potential influenza pandemic.

Among its top concerns is the need for additional resources for an already overburdened public health workforce that may lack the resources to fully respond to a flu outbreak, APHA says. Other needs include clear federal guidance on school closures, quarantine and occupational health in the event of a pandemic.

It is not just the public health sector that should be prepared for a pandemic, says Georges Benjamin, MD, FACP, APHA's executive director.

"The general public must be equipped with the proper resources to prepare themselves in the event of a flu pandemic," Benjamin says. "The better we prepare now, the better our chances will be for protecting the health of Americans during an emergency."

APHA's proposals include:

• Increasing funding for states, localities, hospitals and public health labs to expand their capacity to respond to pandemic flu;
• Increasing investment in the public health work force, so there are enough employees necessary to serve on the frontlines in preparing for and responding to a pandemic and annual seasonal epidemics;
• Creating emergency Medicaid coverage to ensure that uninsured Americans will receive appropriate countermeasures and care in the event ofpandemic flu;
• Creating guidelines for the use of non-pharmaceutical interventions, including handwashing, "snow days," isolation and quarantine;
• Creating new methods to purchase, distribute and track vaccines and antivirals;
• Incorporating occupational and mental health issues, such as potential distress and sick leave from work, in pandemic planning and response efforts; and
• Creating and implementing laws and policies that grant federal, state and local health officers the authority to make decisions about quarantine and isolation orders.
  

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Officials Update Tsunami Recovery Two Years Later

Though the U.S. was among the largest contributors, the global response to the events of December 26, 2004 was essential in meeting the immediate needs of the affected populations of the region and to prevent a secondary disaster due to lack of sanitation and other public health concerns, according to officials who led the effort.

Mark Ward, senior deputy assistant administrator for the U.S. Agency for International Development (USAID), spoke at a tsunami relief and recovery update briefing at theNational Press Club in Washington. The purpose of the event was to provide an update on reconstruction activities in the region in recognition of the second anniversary of the Indian Ocean tsunami. Also speaking was Eric Schwartz, the UN Secretary General's Special Envoy for Tsunami Recovery.

An undersea earthquake in the Indian Ocean occured on Dec. 26, 2004, triggering a series of devastating tsunamis killing more than 275,000 with thousands of others missing, with recent analysis compiled lists a total of 229,866 people lost, including 186,983 dead and 42,883 missing, according to Wikipedia. The catastrophe is one of the deadliest disasters in modern history.

The needed responses were met by the cooperation of the people and governments of the region and by public and private organizations and governmentsaround the world, according to officials who spoke at the Press Club.

In the two years since the tsunami, much work has been done to rebuild lives and livelihoods and U.S. government assistance has totaled more than$840 million in this effort. In addition, U.S. charitable donations haveexceeded $1.8 billion, according to the Center on Philanthropy at Indiana University.

As a result of this generosity, the U.S. is working with the affectedregions to rebuild infrastructure, provide jobs and training (particularly for women), strengthen communities and local governments, and develop early warning systems and effective disaster response programs.

"I'm pleased with our program to date, but more needs to be done," says Ward. "We're building roads that will withstand a tsunami, water sanitation systems, clinics, and homes. We're also providing job training and credit for small businesses. All of this is needed for a self-sufficient recovery."

Ward chaired both the USAID Tsunami Task Force as well as the USAID South Asia Earthquake Task Force and is now leading the U.S. government's Lebanon Reconstruction Task Force.


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